With the advent of genetic
engineering and recombinant DNA technology, it is now possible to produce a
wide variety of human proteins. BCC Research found that these novel
technologies have lifted the market for therapeutic proteins to new heights. Recombinant
DNA technology has created an ease in the manufacturing of protein therapeutics
and is replacing traditional natural methods of extraction. The rising demand
for high-quality recombinant therapeutics is motivating the research and
development of mammalian cell–based manufacturing systems for improved production
yields.

Indeed, protein
therapeutics have become an important segment of the healthcare industry, and
their numbers have increased in recent years. With their many advantages over
small-molecule drugs, protein therapies form a promising market; they are less likely
to interfere with normal biological processes, and they are often well
tolerated. Because of their high specificity and low immunogenicity, protein
therapeutics are widely used to treat various diseases such as cancer,
diabetes, and multiple sclerosis.

In terms of revenue,
monoclonal antibodies are the largest market segment. The increased incidence
of many chronic diseases has driven use of monoclonal antibodies. However, this
segment faces competition from the entry of follow-on biologics. Vaccines are
another growth segment in the biopharmaceutical industry. The improving
economic conditions, increasing public awareness of vaccination, and global
efforts of governments to eradicate viral and bacterial infections are key
drivers. Improved manufacturing technologies have also fueled the vaccines
market.

Improvements in
technologies such as mass spectrometry, advances in molecular genetics, and progress
in production technologies are all key drivers of the protein therapeutics
market. In addition, rapid advances in medical technologies, improved diagnosis
of diseases, and the expansion of healthcare in emerging markets should have a
positive impact on the market. Patent expiries and increasing competition are also
major influences.

The global market for
protein drugs reached $174.7 billion in 2015. At a 5-year compound annual
growth rate (CAGR) of 7.3%, it is predicted to attain $248.7 billion by 2020.
By region, the United States is the largest market, valued at nearly $92
billion in 2015. The United States is also the fastest-growing, and with a
projected 5-year CAGR of 10.9%, the revenue for this region is forecast to be
$154.1 billion by 2020. Europe, which reached $42.2 billion in 2015, is expected
to total $48.1 billion by 2020, reflecting a 5-year CAGR of 2.6%.

The market for protein
drugs is analyzed broadly according to the following types: peptide hormones,
monoclonal antibodies, cytokines, therapeutic enzymes, blood factors, vaccines,
and peptide antibiotics.

Peptide
Hormones

Peptide hormones include human growth
hormones, insulin, erythropoietin, and gonadotropins. Hormonal disorders are on
the rise due to the increase in obesity and decreased physical activity. The introduction
of delivery systems and devices for the convenience of consumers has also boosted
the peptide hormones market. The insulin market is expected to grow in the coming
years due to the increasing diabetic population. And gonadotropins are used for
treatment of infertility disorders, which are expected to rise commensurately as
the childbearing age increases.

The peptide hormone market is
principally divided into growth hormones and erythropoietin. Human growth hormones
have gained importance as therapeutic agents; however, generic versions of some
products are already available. Widespread renal anemia has increased the
demand for erythropoietin, making it a major contributor to the peptide hormone
market. Darbepoetin, a second-generation erythropoietin, allows patients to
administer doses less frequently; therefore, the market share of darbepoetin is
rising.

The global market for peptide hormones
reached $30.4 billion by the end of 2015, bolstered by new drug approvals. A dip
in the erythropoietin segment was in part due to increased competition; the
introduction of less-expensive biosimilars is expected to push the market in a
downward direction. The human growth hormone market remained almost stagnant in
2015; due to the availability of generic drugs, it is not expected to grow much.

Vaccines

In terms of generating revenues,
vaccines are one of the brighter spots for manufacturers. The increasing
acceptance of adult vaccines, public awareness of flu prevention, and
introduction of new vaccines are key growth factors. Various government
programs and increased public awareness of bacterial diseases such as meningitis,
diphtheria, and typhoid have augmented vaccination rates in various countries.
The vaccines market is driven by population growth and the need for therapeutic
vaccines for cirrhosis, liver disease, and primary liver cancer.

The vaccines market is characterized by
moderate growth prospects, higher capital investments, and increased inputs in
research and development activities. With novel manufacturing technologies (for
example, the use of embryonated eggs for influenza vaccines), the time and cost
required to manufacture vaccines are reduced. The World Health Organization has
predicted that widening access to vaccines could prevent 24.6 million to 25.8 million
deaths by the end of the decade.

The overall vaccines market is
forecast to grow well due to innovations and discoveries for newer vaccines against
diseases such as malaria. Viral vaccines represent the largest segment, driven
by the wide spread of diseases such as influenza and hepatitis. The viral
vaccine market has benefitted from governmental awareness programs for diseases
such as polio and measles. There has been significant growth in the bacterial
vaccine market, worth $12.8 billion in 2015. This segment is expected to
continuously grow at a CAGR of 10.9% to 2020.

Therapeutic
Enzymes

Therapeutic enzymes are used to treat enzyme
deficiencies, which can lead to various types of metabolic and enzymatic disorders.
Some enzymatic disorders require enzyme replacement therapy, in which the specific
enzyme that is inactive or absent in affected individuals is replaced with a
functional enzyme molecule that is isolated or produced in a lab. Enzyme therapy
is used for cystic fibrosis, pancreatic insufficiency, and certain cancers.

The global therapeutic enzyme market is
divided into lysosomal enzymes, pancreatic enzymes, and others (mainly
thrombolytic enzymes). Increasing sales of branded products are primarily
driving growth of the overall enzymes market. The global market for therapeutic
enzymes, dominated by the lysosomal segment, reached $6.6 billion in 2015 and
is expected grow at a CAGR of 10.4% to 2020.

Monoclonal
Antibodies

The commercial achievements attributed
to monoclonal antibodies in the last few years are incomparable to any other therapeutic
class. Driving forces for the monoclonal antibodies market include the increasing
incidence of cancer; the specific advantages of monoclonal antibodies as therapeutic
agents; higher demand to address unmet therapeutic needs in immunology and oncology;
and lower competition as the result of accessing novel target space. A broad-spectrum
mode of action is another remarkable advantage of monoclonal antibodies, making
them useful in various diseases. Because of their high specificity, monoclonal
antibodies have become very important as targeted therapies.

The market scenario for monoclonal antibodies
is changing due to launches of biosimilars. The patents of most monoclonal antibodies
are set to expire before 2020. The first biosimilar molecule, which is an
infliximab biosimilar, will be joined by eight others by 2020. The series of launches,
however, may not immediately shake the branded antibody market. The complex
structure of monoclonal antibodies, a long and complicated manufacturing process,
and stringent regulatory requirements will restrict entry of a large number of
biosimilars to the market. The market for human monoclonal antibodies is
anticipated to increase at a CAGR of 16.6% to 2020.

Cytokines

The cytokines market is broadly
characterized as colony stimulating factors, interleukins, and interferons. The
deciding factors for this market have been the launch of hepatitis B and C
cytokine therapies, as well as immunity boosting cytokine therapies. The latter
are used during and after organ transplantations, and to fight infections
during chemotherapy. The global cytokines market is growing moderately. The
increasing number of patients with hepatitis and the price increases of
therapeutic interferons are the driving forces. The availability of biosimilars
in European and other countries is a restricting factor for the cytokines
market.

Interferons led the cytokines market with
$7.1 billion in 2015, followed by granulocyte colony stimulating factors. The interleukin
segment will experience the most growth through 2020, driven by an aging
population across all regions and subsequent increase in incidence of age-related
macular degeneration.

Blood
Factors

Blood factors are a major contributor to
the protein therapeutic industry. More use of blood factors is required as the
incidence of bleeding disorders increases. The aging population is another
growth factor because older people are prone to developing diseases with higher
demand for blood derivatives.

The blood factors market is
principally divided into coagulation factors (the predominant segment) and
immunoglobulins. Recombinant versions of various coagulation factors are the
major drivers for growth of this segment. The global immunoglobulin market is
also growing well, due to continuous demand for immunoglobulin treatments as
well as the approval of existing intravenous immunoglobulin products for new
indications.

The blood factors market is dominated by
sales of coagulation factors, which reached $10.5 billion in 2015 and will likely
increase during the next few years. Products derived through recombinant technology
are less contaminated than those derived through the process of natural extraction,
and thus are more acceptable to manufacturers and consumers. Factors driving
the immunoglobulin market include sales of existing products, increased diagnoses,
and a rise in prophylactic treatment of immune diseases.

Peptide
Antibiotics

Peptide antibiotics (including
cyclosporine, vancomycin, bacitracin, and others) are relatively small
molecules. They act quickly and lethally against a broad spectrum of pathogens
and escape many of the drug-resistance mechanisms. Recent advances in organ
preservation and procurement techniques have contributed to an increasing
number of organ transplants and the development of new peptide antibiotics.

In 2015, cyclosporine was the strongest
segment of the peptide antibiotic market, worth nearly $1.9 billion. The emergence
of antibiotic-resistant bacteria has caused a decline in the use of vancomycin,
which is facing the availability of alternative or new treatment options for invasive methicillin-resistant Staphylococcusaureus infections. The peptide antibioticsmarket has also been negatively affectedby the onset of generics. However, thismarket is expected to rebound as the resultof new approvals in recent years, and toincrease through 2020.

FACTORS AFFECTING THE PROTEIN THERAPEUTIC MARKET

It is expected that the
increase in the aging population and attendant age-related diseases will
inevitably lead to growth in the protein therapeutic market. Chronic conditions
such as diabetes, cancer, autoimmune disorders, and cardiovascular diseases are
becoming more prevalent. According to the World Health Organization, chronic
diseases will become the seventh-leading cause of death worldwide by 2030. By
virtue of their higher efficacy and fewer adverse effects, protein therapeutics
are helpful in treating such diseases. Thus, the increase in persons suffering
from these diseases has led to growth in the protein therapeutic market.

Advancements in manufacturing
technologies are another major factor in the protein therapeutic industry.
Traditionally, proteins were extracted from human or other biologic resources.
For example, vaccines were made using egg cultures. However, with the advent of
recombinant DNA technology, manufacturers can now produce large quantities of
vaccines using genetically modified organisms. Blood products were initially
extracted from human plasma; however, they are now manufactured using DNA
technology, either in bacterial expression systems or in mammalian cell culture
systems. Growth in the protein therapeutic market is likely to mirror these
advances in manufacturing technologies.

The high cost of protein
therapeutics is a major challenge. High product prices result in the unavailability
of certain therapies that are required by patients for quick and effective
recovery. At the same time, prices are controlled by law in many countries.
Government agencies regulate prices through their control of national healthcare
organizations, which can bear a large part of the cost for supplying medicines
to consumers. European governments are adopting aggressive pricing strategies
to exert downward pressure on drug costs. Healthcare reforms in countries such
as France, Spain, and Germany have controlled pricing and authorized generics.
In the United States, there are no government price controls over private
sector purchases, but federal law requires manufacturers to pay rebates on
certain medicines to be eligible for reimbursement under several state and
federal healthcare programs.

The healthcare and medical
industries are highly regulated. Regional/country-specific laws and regulations
are important determinants of whether a product can be successfully developed
and approved. The benefit-to-risk evaluation continues to be a chief consideration
in the approval of new medicines, and regulatory authorities are increasingly
focusing on the safety of medications during the post-approval phase. Every
country governs its own laws of regulation, making it harder for manufacturers to
meet the requirements for each. Therefore, regulatory pressures create a
challenge in the market for protein therapeutics.

Finally, the availability
of biosimilars in European and other countries is a restricting factor for the
protein therapeutics market. Many top-selling drugs are approaching patent
expiry, paving the way for biosimilars. In March 2015, the US FDA approved the first
biosimilar in the United States, Zarxio, for filgrastim. Thus, the North
American market scenario is expected to change with the onset of biosimilars.

This article is based on the following market analysis report
published by BCC Research: Global Markets and Manufacturing Technologies for
Protein Drugs (BIO021E) by Shalini Shahani Dewan. For more information, visit www.bccresearch.com.

Shalini
S. Dewan earned her MS in Pharmaceutical Chemistry and has more than 14 years
of industry experience. She was awarded a Gold Medal by the Prime Minister of
India for her work and has worked with top companies in India and in the US.
Some of her other reports for BCC Research include: Global Markets and Technologies
for Advanced Drug Delivery Systems, Orthopedic Drugs, Implants and Devices and
Global Markets for Reagents for Chromatography.

Laurie
L. Sullivan, ELS, is a Boston-based writer and editor with 20 years of experience
in medical communications. She is certified by the Board of Editors in the Life
Sciences. She contributes regularly to the BCC Research blog focusing on Life
Sciences.